RealTimeRecalls & reported problems across all models

We found 4 models of RealTime by Abbott Molecular Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Sep 9, 2022 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (42 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RealTime problems

RealTime models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RealTime 09N77-095

  Reagents, 2019-novel coronavirus nucleic acid
  57 reports
• RealTime 6L18-90

  Test, hiv detection
  12 reports
• RealTime 08N90-090

  Somatic gene mutation detection system
  2 reports
• RealTime 8L07-91

  DEVICE, SPECIMEN COLLECTION
  1 report

Recent RealTime adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 9, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULT ON THE ABBOTT REALTIME IDH1 ASSAY. THE CUSTOMER REPORTED A DISCREPANT RESULT FOR THE R132H MUTATION WHILE USING THE ABBOTT REALTIME IDH1 ASSAY. SAMPLE ID (SID) (B)(6) WAS TESTED ON (B)(6) 2022, AND THE RESULT WAS "NOT DETECTED" FOR THE R132H MUTATION. THE NEGATIVE RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN. THE PHYSICIAN CONTACTED THE CUSTOMER'S LABORATORY TO LET THEM KNOW THAT THE PATIENT'S SAMPLE WAS RE-TESTED AT A DIFFERENT LABORATORY AND THE RESULT WAS "DETECTED: FOR THE R132H MUTATION. IT IS NOT KNOWN WHY THE PHYSICIAN QUESTIONED THE RESULT AND HAD ANOTHER TEST PERFORMED AT A DIFFERENT LABORATORY. THE SAMPLE WAS THEN RETESTED USING THREE DIFFERENT SAMPLES IN THE CUSTOMER'S LABORATORY ON (B)(6) 2022. THE THREE SAMPLES WERE THE ORIGINAL EXTRACTED MATERIAL, FRESHLY EXTRACTED MATERIAL FROM THE ORIGINAL PATIENT SAMPLE VIAL (SID (B)(6)), AND MATERIAL PROVIDED BY THE OUTSIDE LABORATORY (SID (B)(6)). ALL THREE SAMPLES (FROM THE SAME PATIENT) HAD MUTATION R132H DETECTED. THE EFFECT ON THE PATIENT'S HEALTH MANAGEMENT IS NOT KNOWN. A MEDICAL OPINION WAS OBTAINED FOR THE POTENTIAL DELAY IN TREATMENT FOR > 5 DAYS AND CONCLUDED IN A WORST-

  Patient problems: Insufficient Information

  MAUDE report 15392990 ↗
• MalfunctionMar 3, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON THE REALTIME SARS-COV-2 ASSAY. THE PATIENT SAMPLE WAS TESTED TWICE ON THE SAME RUN. ONE RESULT WAS "NOT DETECTED" AND THE OTHER RESULT WAS POSITIVE. THE CUSTOMER REPORTED THE NEGATIVE RESULT OUT OF THE LAB AND DID NOT SEE ANY FURTHER NEED FOR REPEAT TESTING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN MACEDONIA USING THE REALTIME SARS-COV-2 ASSAY, LIST NUMBER 9N77-90, WHICH IS THE SAME/ SIMILAR TO THE REALTIME SARS-COV-2 ASSAY, LIST NUMBER 9N77-95, WHICH RECEIVED FDA EUA APPROVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664929 ↗
• MalfunctionFeb 14, 2022False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT AT LEAST 6 FALSE POSITIVE RESULTS, LATER CLARIFIED AS 10, WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER NOTIFIED ABBOTT THAT THE LAB STAFF IS REPEATING ALL REALTIME SARS-COV-2 PATIENT SAMPLES THAT GENERATE A POSITIVE RESULT WITH A CYCLE NUMBER (CN) OVER 28. ALL SARS-COV-2 PATIENT SAMPLES REPORTED AS POSITIVE BY THE ASSAY ARE REVIEWED BY LAB STAFF. ANY POSITIVE SAMPLE WITH CN AT 28 OR MORE ARE REPEATED ON THE CUSTOMER'S SECOND M2000 SYSTEM. THE SAME SAMPLE ALIQUOT IS USED TO PERFORM THE SECONDARY TEST. REPEATED RESULT IS NEGATIVE. CONFIRMATION TESTING IS DONE ON BDMAX AND CEPHEID PANELS (SAME ALIQUOT), AND THE RESULT IS NEGATIVE FOR ALL PREVIOUSLY POSITIVE SAMPLES WITH CN 28 AND OVER. REVIEW BY GLOBAL SERVICE AND SUPPORT INDICATES THAT LOG FILE ANALYSIS CONCLUDED THERE IS NO INDICATION OF ANY SYSTEM OR REAGENT PERFORMANCE ISSUES. NINE OF THE TEN DISCREPANT RESULTS ARE MOST LIKELY ATTRIBUTED TO THE VIRAL CONCENTRATIONS NEAR OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. DISCUSSION WITH THE CUSTOMER OFFERED RESOLUTION FOR REPORTING LOW-GRADE POSITIVE SARS-COV-2 ASSAY RESULTS RATHER THAN HAVING THE SAMPLES RE-TESTED. IN THE FUTURE, THE CUSTOMER WILL INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529476 ↗
• MalfunctionFeb 14, 2022False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT AT LEAST 6 FALSE POSITIVE RESULTS, LATER CLARIFIED AS 10, WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER NOTIFIED ABBOTT THAT THE LAB STAFF IS REPEATING ALL REALTIME SARS-COV-2 PATIENT SAMPLES THAT GENERATE A POSITIVE RESULT WITH A CYCLE NUMBER (CN) OVER 28. ALL SARS-COV-2 PATIENT SAMPLES REPORTED AS POSITIVE BY THE ASSAY ARE REVIEWED BY LAB STAFF. ANY POSITIVE SAMPLE WITH CN AT 28 OR MORE ARE REPEATED ON THE CUSTOMER'S SECOND M2000 SYSTEM. THE SAME SAMPLE ALIQUOT IS USED TO PERFORM THE SECONDARY TEST. REPEATED RESULT IS NEGATIVE. CONFIRMATION TESTING IS DONE ON BDMAX AND CEPHEID PANELS (SAME ALIQUOT), AND THE RESULT IS NEGATIVE FOR ALL PREVIOUSLY POSITIVE SAMPLES WITH CN 28 AND OVER. REVIEW BY GLOBAL SERVICE AND SUPPORT INDICATES THAT LOG FILE ANALYSIS CONCLUDED THERE IS NO INDICATION OF ANY SYSTEM OR REAGENT PERFORMANCE ISSUES. NINE OF THE TEN DISCREPANT RESULTS ARE MOST LIKELY ATTRIBUTED TO THE VIRAL CONCENTRATIONS NEAR OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. DISCUSSION WITH THE CUSTOMER OFFERED RESOLUTION FOR REPORTING LOW-GRADE POSITIVE SARS-COV-2 ASSAY RESULTS RATHER THAN HAVING THE SAMPLES RE-TESTED. IN THE FUTURE, THE CUSTOMER WILL INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529459 ↗
• MalfunctionJan 31, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE REALTIME SARS-COV-2 ASSAY. CUSTOMER STATES THERE WERE 10 PATIENT SPECIMENS THAT WERE HIGH CN POSITIVES. THEY WERE REPEATED ON THE ALINITY M INSTRUMENT AS NEGATIVE. THE MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED THE LOGS. THERE WAS NO INDICATION OF A CARRYOVER EVENT. THE CUSTOMER CONFIRMED THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE RESULTS WERE NOT REPORTED OUT AS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391987 ↗
• MalfunctionOct 1, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 14 FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. THE CUSTOMER RETESTED 15 SAMPLES WHICH HAD TESTED POSITIVE ON THE REALTIME SARS-COV-2 ASSAY AFTER THE PATIENT FACILITY QUESTIONED THE RESULTS. THE RETESTS WERE PERFORMED ON THE HOLOGIC APTIMA ASSAY AND 14 OF THE SAMPLES YIELDED NEGATIVE RESULTS. THE CUSTOMER COULD NOT PROVIDE ANY INFORMATION ABOUT IF THERE WAS ANY IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER SITE PROVIDED ADDITIONAL INFORMATION TO CLARIFY THEIR OBSERVATIONS. AN INVESTIGATION WAS INITIATED WITH 67 M2000 RUNS EXAMINED, FOR A TOTAL OF 5750 SAMPLES. OF THOSE 5750 SAMPLES, 44 SAMPLES HAD CYCLE NUMBERS (CN) OF 25.0 - 31.5, WHICH YIELDED 0.77% OF SAMPLES WITH HIGH CN. CUSTOMER DID NOT REPEAT ANY OF THOSE SAMPLES, HOWEVER AFTER THE INVESTIGATION, IT WAS DECIDED TO REPEAT ANY SAMPLES >25CN ON ANOTHER PLATFORM TO CONFIRM. A LONG TERM FACILITY QUESTIONED POSITIVE COVID RESULTS FROM VACCINATED PATIENTS: ON (B)(6) 2021, THE LONG TERM CARE FACILITY QUESTIONED A POSITIVE COVID RESULT FROM A VACCINATED PATIENT. THE SPECIMEN WAS RECEIVED (B)(6) 2021 AND WAS RUN ON THE ABBOTT M2000 INSTRUMENT WITH A RESULT OF 31.13 CN. THE CUTOFF VALUE FOR THIS ASSAY IS 31

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565843 ↗
• MalfunctionJul 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER SITE PROVIDED ADDITIONAL INFORMATION TO CLARIFY THEIR OBSERATIONS. AN INVESTIGATION WAS INITIATED WITH 67 M2000 RUNS EXAMINED, FOR A TOTAL OF 5750 SAMPLES. OF THOSE 5750 SAMPLES, 44 SAMPLES HAD CYCLE NUMBERS (CN) OF 25.0 - 31.5, WHICH YIELDED 0.77% OF SAMPLES WITH HIGH CN. CUSTOMER DID NOT REPEAT ANY OF THOSE SAMPLES, HOWEVER AFTER THE INVESTIGATION, IT WAS DECIDED TO REPEAT ANY SAMPLES >25CN ON ANOTHER PLATFORM TO CONFIRM. A LONG TERM FACILITY QUESTIONED POSITIVE COVID RESULTS FROM VACCINATED PATIENTS: ON (B)(6) 2021, THE LONG TERM CARE FACILITY QUESTIONED A POSITIVE COVID RESULT FROM A VACCINATED PATIENT. THE SPECIMEN WAS RECEIVED (B)(6) 2021 AND WAS RUN ON THE ABBOTT M2000 INSTRUMENT WITH A RESULT OF 31.13 CN. THE CUTOFF VALUE FOR THIS ASSAY IS 31.5 CN, SO ALTHOUGH THIS SAMPLE WAS RESULTED AS POSITIVE, IT WAS VERY CLOSE TO THE CUTOFF. THIS SAMPLE WAS THE ONLY POSITIVE ON THE RUN, AND THE QUALITY CONTROL (QC) WAS ACCEPTABLE. AFTER THE FACILITY SAW THIS SAMPLE WAS POSITIVE, THEY SUBMITTED A SECOND SAMPLE ON (B)(6) 20201. THE SECOND SAMPLE WAS RUN ON THE PANTHER ON (B)(6) 2021, AND IT WAS NEGATIVE. BOTH SAMPLES WERE SUBSEQUENTLY RUN ON THE TAQPATH ASSAY ON 3/19/2021, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185643 ↗
• MalfunctionJul 15, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT RESULT OF FALSE POSITIVE WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. PER THE CUSTOMER, THE NASOPHARYNGEAL SAMPLE WAS COLLECTED AT A REMOTE LOCATION AND TRANSPORTED REFRIGERATED. THE SAMPLE WAS STORED REFRIGERATED IN THE LAB. CUSTOMER REQUESTED THE MOLECULAR APPLICATION SPECIALIST (MAS) TO PERFORM A LOG REVIEW. THE MAS REVIEWED AMPLIFICATION CURVES FOR THE RUNS IN QUESTION AND DETERMINED THAT FIRST SAMPLE ON (B)(6) GENERATED A POSITIVE RESULT. IT WAS CONFIRMED THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS RETESTED AT THE PHYSICIAN'S REQUEST. THE SAME SAMPLE WAS RE-RUN ON (B)(6) AND THE RESULT WAS NEGATIVE. PHYSICIAN WAS NOTIFIED OF THIS CORRECTED RESULT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT DUE TO THIS OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173992 ↗
• MalfunctionJun 24, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT RESULT OF FALSE POSITIVE WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER REQUESTED THE MOLECULAR APPLICATION SPECIALIST TO PERFORM A LOG REVIEW FOR SAMPLE (B)(6) COLLECTED IN A UNIVERSAL MULTI-COLLECT TUBE, WHICH WAS RUN THREE TIMES. THE CUSTOMER STATED THEY WERE CONCERNED BECAUSE THE THIRD SAMPLING WOULD HAVE MADE THE MINIMUM VOLUME LOWER THAN THAT SPECIFIED IN THE REALTIME SARS COV-2 PACKAGE INSERT. THE CUSTOMER LATER REVEAL THE FIRST SAMPLING YIELDED A NEGATIVE RESULT. THE SAME WAS RE-RUN AS A KNOWN NEGATIVE, BUT IT RESULTED POSITIVE IN SUBSEQUENT RUNS. PER THE CUSTOMER, THE NASOPHARYNGEAL SAMPLE WAS COLLECTED AT A REMOTE LOCATION AND TRANSPORTED REFRIGERATED. THE SAMPLE WAS STORED REFRIGERATED IN THE LAB AND ALL SAMPLINGS OF IT WERE PERFORMED WITHIN 72 HOURS OF COLLECTION. THE MOLECULAR APPLICATION SPECIALIST (MAS) ADVISED CUSTOMER TO PERFORM AN ENVIORNMENTAL CONTAMINATION CHECK AND MAKE SURE ENVIRONMENTAL MONITORING IS UP-TO-DATE. MAS REVIEWED AMPLIFICATION CURVES FOR THE RUNS IN QUESTION AND DETERMINED THAT THE CURVES APPEAR VALID, WITH NO NOISE. MAS DID NOTICE THE SAMPLE IN QUESTION WAS ADJACENT TO A HIGH POSITIVE SAMPLE ON THE PLATE. MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061486 ↗
• MalfunctionJun 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 17 FALSE POSITIVE RESULTS ON 2 RUNS OF THE REALTIME SARS-COV-2 ASSAY. THE CUSTOMER INITIALLY QUESTIONED THE RESULTS BECAUSE SOME OF THE PATIENTS ON THE RUN WERE PRE SURGERY SCREENINGS AND WERE NOT EXPECTED TO BE POSITIVE. SOME OF THE SAMPLES ALSO TESTED POSITIVE ON CEPHID, WHICH LED THE CUSTOMER TO SUSPECT CONTAMINATION OF THE ORIGINAL SAMPLES DUE TO HANDLING. FOR THOSE SAMPLES THAT WERE POSITIVE ON BOTH ASSAYS, THE CUSTOMER COLLECTED NEW SAMPLES AND TESTED THEM ON ANOTHER PLATFORM GENERATING A NEGATIVE RESULT. SOME PATIENT SURGERIES HAD TO BE RESCHEDULED OR CANCELLED, SO THERE WAS AN IMPACT TO PATIENT MANAGEMENT WITH NO REPORT OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009991 ↗
• MalfunctionMay 11, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 21 FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. THE CUSTOMER SUSPECTED CONTAMINATION ON THEIR M2000RT INSTRUMENT, SO THEY RETESTED ALL 21 SAMPLES ON AN ALINITY M INSTRUMENT AND RECEIVED NEGATIVE RESULTS. THE POSITIVE RESULTS WERE NOT REPORTED OUTSIDE THE LAB, SO THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810157 ↗
• MalfunctionMar 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED EIGHT FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. REVIEW OF THE AMPLIFICATION CURVES INDICATE THE SAMPLES HAVE A POSITIVE CYCLE NUMBER VALUE, BUT SHOW NO AMPLIFICATION. THE CUSTOMER RETESTED THE SAMPLES ON AN ALINITY M INSTRUMENT AND GOT NEGATIVE RESULTS. THE FALSE POSITIVE RESULTS WERE NOT REPORTED OUT OF THE LAB, SO THERE WAS NO IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558489 ↗
• MalfunctionMar 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. A PATIENT TESTED POSITIVE FOR SARS-COV-2 ON THE REALTIME SARS-COV-2 ASSAY ON (B)(6). A PHYSICIAN QUESTIONED THE RESULTS, SO THEY WERE RETESTED THE FOLLOWING DAY WITH A NEW SAMPLE, (B)(6), WITH NEGATIVE RESULTS. THE PATIENT HAD ALSO TESTED NEGATIVE ON (B)(6) WITH A THIRD DIFFERENT SAMPLE. ALL ASSAY PARAMETERS, SUCH AS ASSAY CONTROLS, INTERNAL CONTROL, REFERENCE DYE PERFORMED AS PER SPECIFICATIONS. THE CUSTOMER WAS NOT ABLE TO BE REACHED AFTER BEING CONTACTED THREE SEPARATE TIMES FOR ADDITIONAL INFORMATION. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554132 ↗
• MalfunctionJan 27, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED ONE PATIENT SAMPLE FROM EARLY JANUARY 5TH GENERATED A POSITIVE RESULT FOR REALTIME SARS-COV-2 ASSAY, WHICH WAS DISPUTED BY THE PHYSICIAN. SAMPLE WAS COLLECTED, TRANSPORTED TO THE LAB, AND TESTED ON THE SAME DAY. THIS PATIENT HAS BEEN DOING REGULAR COVID TESTING AND HAS BEEN NEGATIVE ON THE PREVIOUS TWO TESTS. THE RESULT WAS OBTAINED EARLY IN THE MORNING AND FORWARDED TO PHYSICIAN. THE POSITIVE RESULT WAS DISPUTED BY PATIENT'S PHYSICIAN AND REPEATED ON AN ALTERNATIVE PLATFORM, AND THE RESULT WAS NEGATIVE. THE SAME SAMPLE TUBE WAS USED FOR THE RE-TEST ON THE ALTERNATIVE PLATFORM. THE CUSTOMER WAS INSTRUCTED TO MAKE SURE NO CONTAMINATION IS PRESENT IN PROCESSING, AS A POSSIBLE CONTAMINATION COULD BE THE CAUSE OF THE POSITIVE RESULT. THE LAB DIRECTOR IS EXTREMELY FAMILIAR WITH DECONTAMINATION METHODS. FOLLOWING THE CALL AND DISCUSSION WITH CUSTOMER, INSTRUMENT AND THE LAB HAVE BEEN THOROUGHLY CLEANED AND ENVIRONMENTAL CHECKS WERE PERFORMED TO CONFIRM ABSENSE OF ANY DETECTABLE CONTAMINATION. FINAL IMPACT ON PATIENT MANAGEMENT IS NOT KNOWN, AS PER CUSTOMER; HOWEVER THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT AS THE RESULT WAS QUESTIONED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238918 ↗
• MalfunctionDec 11, 2020False Positive Result; False Positive Result

  CUSTOMER STATED THAT THEY HAVE EXPERIENCED DISCREPANT RESULTS WITH THE REALTIME SARS-COV-2 ASSAY. CUSTOMER STATED THAT THEY HAVE EXPERIENCED 1-3 DISCREPANT RESULTS PER (B)(4) SINCE (B)(4). CUSTOMER CONFIRMED THROUGH ENVIRONMENTAL TESTING THAT NO ENVIRONMENTAL CONTAMINATION EXISTS. CUSTOMER NOTED AN ODD LATE RISING TARGET CURVE FOR THESE SPECIMENS. CUSTOMER REPEATED THESE SAMPLES ON CEPHEID, AND THEY GENERATE A NEGATIVE RESULT. ALLEGED FALSE POSITIVE RESULTS ARE NOT RELEASED, RATHER SUCH QUESTIONABLE RESULTS ARE RE-TESTED ON CEPHEID. IMPACT ON PATIENT MANAGEMENT FOR SAMPLES IN QUESTION IS NOT KNOWN; HOWEVER AS QUESTIONED REALTIME RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY THESE QUESTIONED RESULTS WERE NOT MADE AVAILABLE TO HAVE IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992643 ↗

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