Seraclone® Anti-C (RH2) 802280100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969950348), received between Sep 6, 2018 and Aug 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT ANTIGEN TESTING RESULTS WITH SERACLONE ANTI-C.THE CUSTOMER REPORTED A FALSE POSITIVE TEST RESULT WITH A BLOOD UNIT FROM A DONOR KNOW AS NEGATIVE FOR ANTI-C ANTIGEN: DONOR UNIT (B)(6), NEGATIVE AND TESTED (B)(6) 2023 WITH A PREVIOUS LOT OF PRODUCTS, 9229030-01 (EXP. 13.10.2023, MANUF. 20.07.2022). DONOR UNIT (B)(6), NEGATIVE AND TESTED (B)(6) 2024 WITH THE PRODUCT LOT REPORTED, 9347050-01 (EXP. 15.02.2025, MANUF. 23.11.2023). DONOR UNIT (B)(6), POSITIVE 2+ REPEATABLE WITH ANOTHER VIAL FROM SAME PRODUCT LOT AND TESTED (B)(6) 2024 WITH THE PRODUCT LOT REPORTED, 9347050-01 (EXP. 15.02.2025, MANUF. 23.11.2023). ACCORDING TO THE LAST VERSION OF IFU, V13 APPLICABLE SINCE 30.08.2021, THE CLONE IS MS24. THE OTHER LOT 9229030-01 PREVIOUSLY USED BY THE CUSTOMER HAS BEEN MANUFACTURED 20.07.2022. THEREFORE, THESE TWO LOTS USED BY THE CUSTOMER CONTAIN THE SAME CLONE MENTIONED IN THE LAST VERSION OF IFU, THERE IS NO CHANGE REGARDING THE CLONE. ACCORDING TO THE ADDITIONAL INFORMATION, THE CUSTOMER CONFIRMED THAT THESE THREE RBC BLOOD UNITS ARE FROM THE SAME DONOR. AND THE QC TESTS ARE NOT PERFORMED WITH BIO-RAD REAGENT. IN VIEW OF THE DATE OF TESTS PERFORMED BY THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791321 ↗
• MalfunctionApr 13, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A DONOR SAMPLE WITH THE BLOOD GROUPING REAGENT SERACLONE ANTI-C (RH2). THE CUSTOMER STATED THAT THE DONOR WAS PREVIOUSLY TESTED AS C-ANTIGEN NEGATIVE SEVERAL TIMES IN THE PAST. THE CUSTOMER RETURNED A PRODUCT SAMPLE OF THE SUPPOSEDLY DEFECTIVE SERACLONE ANTI-C LOT FOR INVESTIGATIONAL TESTING AND ADDITIONALLY TWO SEGMENTS OF THE DONOR IN QUESTION. FIRST, OUR QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER IN PARALLEL WITH THEIR RETENTION SAMPLE FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER 16 WAS EXCEEDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THEN OURQUALITY CONTROL LABORATORY TESTED THE SEGMENTS WITH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH AN INCUBATION FOR 10 MINUTES AT ROOM TEMPERATURE. BOTH SEGMENTS SHOWED POSITIVE REACTIONS. BECAUSE THE COMPLAINT SAMPLE WAS EXHAUSTED ONLY THE RETENTION SAMPLE WAS USED FOR THE FURTHER TESTING: THE SEGMENTS WERE INCUBATED ONLY FIVE MINUTES AT ROOM TEMPERATURE. AGAIN, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731195 ↗
• MalfunctionSep 6, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A DISCREPANT TEST RESULT OF A REAGENT RED BLOOD CELL COMPARED TO THE ANTIGEN PROFILE WORKSHEET. A PATIENT WITH A KNOWN ANTI-P1 REACTED WEAKLY POSITIVE WITH A REAGENT RED BLOOD CELL ON THEIR IMMUCOR PANEL (LOT #23324, CELL #8) THAT WAS DENOTED AS P1 NEGATIVE ON THE ANTIGEN PROFILE WORKSHEET. THE DISCREPANT CELL #8 WAS TESTED WITH SERACLONE ANTI-P1 LOT #8736030-00 IN COMPARISON. IT REACTED WEAKLY POSITIVE AFTER 5 MINUTES OF INCUBATION AND YIELDED A 1+ POSITIVE REACTION AFTER 10 MINUTES OF INCUBATION AT ROOM TEMPERATURE. THE CUSTOMER ALSO FILED A COMPLAINT WITH IMMUCOR AND REQUESTED AN INVESTIGATION. IMMUCOR REPORTED THAT THEY COULD NOT DUPLICATE THE REPORTED REACTIVITY. THE CUSTOMER PROVIDED THE IMMUCOR PANEL CELL #8 (LOT #23324), THE PATIENT SAMPLE AND ALSO THE COMPLAINT REAGENT SERACLONE ANTI-P1 LOT #8736030-00 FOR INVESTIGATIONAL TESTING. THE IMMUCOR PANEL LOT WAS ALREADY EXPIRED AT THE TIME THE CUSTOMER FILED HIS COMPLAINT WITH BIO-RAD. IN ORDER TO DEMONSTRATE THE CORRECT REACTIVITY OF THE REAGENT SERACLONE ANTI-P1 IT WAS TESTED AGAINST THE PANEL CELL #8 ALTHOUGH THE EXPIRATION DATE WAS EXCEEDED. AN ANTIBODY IDENTIFICATION OF THE PATIENT SAMPLE USING THE GEL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7849942 ↗