BC Thrombin Reagent 10446636Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842768013102), received between Sep 1, 2017 and Nov 2, 2017 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K970645); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2017High Test Results; High Test Results

  A CUSTOMER PERFORMED A NORMAL REFERENCE RANGE VERIFICATION STUDY USING DONOR SAMPLES FOR BOTH BC THROMBIN REAGENT LOTS (517469 (KIT LOT# 47184) AND 517467 (KIT LOT # 46348)) AND VERIFIED THEIR CURRENT NORMAL REFERENCE RANGE OF 0-20.9 SECONDS. WHEN THE CUSTOMER REPEATED THE VALIDATION STUDY WITH 20 LOCAL DONORS USING LOT 517469, THEY OBSERVED THAT SOME RESULTS EXCEEDED THE UPPER LIMIT OF THEIR NORMAL REFERENCE RANGE. THE CUSTOMER ALSO RAN A COMPARISON STUDY BETWEEN THE TWO BC THROMBIN REAGENT LOTS AND OBSERVED HIGHER QC RECOVERY AND PATIENT RESULTS USING LOT 517469. THE RESULTS FROM THE CORRELATION STUDY FOR LOT 517469 DID NOT MEET THE LAB'S ACCEPTANCE CRITERIA. HOWEVER, THE CUSTOMER INDICATED THAT THE POSITIVE BIAS OBSERVED WITH LOT 517469 DOES NOT IMPACT THE QUALITATIVE VALUES FOR PATIENTS AND THEY APPROVED THE USE OF LOT 517469. BASED ON THE POSITIVE BIAS, THE CUSTOMER ADJUSTED THE UPPER LIMIT OF THEIR NORMAL REFERENCE RANGE FROM 20.9 SECONDS TO 23 SECONDS. THEY EXPRESSED A CONCERN REGARDING INCREASE USAGE OF HEPZYME ON PATIENT SAMPLES AS THEY USE HEPZYME ON ALL RESULTS EXCEEDING 30 SECONDS. THE CUSTOMER STARTED USING THE NEW LOT ON (B)(6) 2017. THERE ARE NO KNOWN REPORTS OF PATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995849 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  ELEVATED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON TWO BCS XP SYSTEMS USING BC THROMBIN REAGENT LOT 517468 (KIT LOT 46751). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CA-660 SYSTEM USING AN ALTERNATE TEST THROMBIN REAGENT, RESULTING LOWER. THE RESULTS OBTAINED ON THE SYSMEX CA-660 SYSTEM WERE REPORTED TO THE PHYSICIAN. WHILE THE INTERNAL QUALITY CONTROLS WERE WITHIN RANGE ON THE SYSMEX CA-660 SYSTEM, IT IS UNKNOWN IF QC WERE WITHIN RANGE ON THE BCS XP SYSTEMS AT THE TIME OF THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995321 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  ELEVATED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON TWO BCS XP SYSTEMS USING BC THROMBIN REAGENT LOT 517468 (KIT LOT 46751). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE RERUN ON AN ALTERNATE SYSMEX CA-660 SYSTEM USING AN ALTERNATE TEST THROMBIN REAGENT, RESULTING LOWER FOR MOST SAMPLES. THE RESULT OBTAINED ON THE SYSMEX CA-660 RECOVERED HIGHER FOR (B)(6). THE RESULTS OBTAINED ON THE SYSMEX CA-660 SYSTEM WERE REPORTED TO THE PHYSICIAN. INTERNAL QUALITY CONTROLS WERE WITHIN RANGE ON ALL SYSTEMS AT THE TIME OF EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995317 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  A SIEMENS' DISTRIBUTOR REPORTED THAT TWO OF THEIR CUSTOMERS REJECTED THE USE OF BC THROMBIN REAGENT LOT 517468 (KIT LOT # 46751) AFTER THEY PERFORMED A CORRELATION STUDY ON PATIENT SAMPLES BETWEEN THEIR PREVIOUS BC THROMBIN REAGENT LOT 517467 AND LOT 517468 ON A BCS XP SYSTEM. BOTH CUSTOMERS OBSERVED AN INCREASE IN THROMBIN TIME (TT) RECOVERY ON PATIENT SAMPLE RESULTS AND WHEN THEY RAN INTERNAL QUALITY CONTROL (QC) (CONTROL PLASMA N), THEY REPORTED HIGH QC RECOVERY. THE SIEMENS' DISTRIBUTOR INDICATED THAT CONTROL PLASMA NORMAL LOT 507734 AND 507740 WERE RUN USING BC THROMBIN REAGENT LOT 517469 (KIT LOT # 47184) AND THE QUALITY CONTROLS RECOVERED WITHIN RANGE AND NORMAL PATIENT RESULTS RECOVERED WITHIN THE REFERENCE RANGE FOR THROMBIN TIME. THE DISTRIBUTOR INDICATED THAT (B)(6) WILL START USING BC THROMBIN REAGENT LOT 517469. IT IS UNKNOWN IF THIS CUSTOMER IS REPORTING RESULTS USING LOT 517469. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH QC AND PATIENT SAMPLE RECOVERY ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995316 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  ELEVATED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON TWO BCS XP SYSTEMS USING BC THROMBIN REAGENT LOT 517468 (KIT LOT 46751). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CA-660 SYSTEM USING AN ALTERNATE TEST THROMBIN REAGENT, RESULTING LOWER. THE RESULTS OBTAINED ON THE SYSMEX CA-660 SYSTEM WERE REPORTED TO THE PHYSICIAN. WHILE THE INTERNAL QUALITY CONTROLS (QC) WERE WITHIN RANGE FOR BCS XP SYSTEM SERIAL NUMBER (B)(4) AND THE SYSMEX CA-660 SYSTEM, IT IS UNKNOWN IF THE INTERNAL QC WERE WITHIN RANGE FOR BCS XP SYSTEM SERIAL NUMBER (B)(4) AT THE TIME OF THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995315 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  ELEVATED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON TWO BCS XP SYSTEMS USING BC THROMBIN REAGENT LOT 517468 (KIT LOT 46751). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CA-660 SYSTEM USING AN ALTERNATE TEST THROMBIN REAGENT, RESULTING LOWER FOR MOST SAMPLES. THE RESULT OBTAINED ON THE SYSMEX CA-660 SYSTEM RECOVERED HIGHER FOR (B)(6). THE RESULTS OBTAINED ON THE SYSMEX CA-660 SYSTEM WERE REPORTED TO THE PHYSICIAN. WHILE THE INTERNAL QUALITY CONTROLS (QC) RECOVERED WITHIN RANGE ON THE SYSMEX CA-660 SYSTEM AND BCS XP SYSTEM SERIAL (B)(4), THE QC RECOVERED HIGH OUT OF RANGE ON THE BCS XP SYSTEM SERIAL (B)(4). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995314 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  ELEVATED THROMBIN TIME (TT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON TWO BCS XP SYSTEMS USING BC THROMBIN REAGENT LOT 517468 (KIT LOT 46751). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). MOST SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CA-660 SYSTEM USING AN ALTERNATE TEST THROMBIN REAGENT, RESULTING LOWER. THE RESULTS OBTAINED ON THE SYSMEX CA-660 SYSTEM WERE REPORTED TO THE PHYSICIAN. INTERNAL QUALITY CONTROLS (QC) WERE WITHIN RANGE ON ALL THREE SYSTEMS AT THE TIME OF EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995312 ↗
• MalfunctionNov 1, 2017High Test Results; High Test Results

  A SIEMENS' DISTRIBUTOR REPORTED THAT ONE OF THEIR CUSTOMERS ((B)(6)) REJECTED THE USE OF BC THROMBIN REAGENT LOT 517468 (KIT LOT # 46751) AFTER THEY PERFORMED A CORRELATION STUDY ON PATIENT SAMPLES BETWEEN THEIR PREVIOUS BC THROMBIN REAGENT LOT 517467 AND LOT 517468 ON A BCS XP SYSTEM. THEY OBSERVED AN INCREASE IN THROMBIN TIME (TT) RECOVERY ON PATIENT SAMPLE RESULTS AND WHEN THEY RAN INTERNAL QUALITY CONTROL (QC) (CONTROL PLASMA N), THEY REPORTED HIGH QC RECOVERY. THE DISTRIBUTOR INDICATED THAT CONTROL PLASMA NORMAL LOT 507734 AND 507740 WERE RUN USING BC THROMBIN REAGENT LOT 517469 (KIT LOT # 47184) AND THE QUALITY CONTROLS RECOVERED WITHIN RANGE AND NORMAL PATIENT RESULTS RECOVERED WITHIN THE REFERENCE RANGE FOR THROMBIN TIME. THE DISTRIBUTOR INDICATED THAT (B)(6) WILL START USING BC THROMBIN REAGENT LOT 517469. IT IS UNKNOWN IF THE CUSTOMER IS REPORTING RESULTS USING LOT 517469. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH QC AND PATIENT SAMPLE RECOVERY ON THE BCS XP SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995311 ↗
• MalfunctionSep 1, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ELEVATED THROMBIN TIME (TT) PATIENT SAMPLE RESULTS WERE OBTAINED ON THE BCS XP SYSTEM WITH BC THROMBIN LOT 517468 (KIT LOT # 46751) AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER INDICATED THAT THE ELEVATED TT RESULTS MAY POTENTIALLY LEAD TO A DELAY IN PLANNED PATIENT TREATMENT, BUT NO PATIENTS WERE CLINICALLY IMPACTED. THE CUSTOMER INDICATED THE AVERAGE TT RESULTS FOR NORMAL PATIENTS INCREASED WITH BC THROMBIN LOT 517468 COMPARED TO BC THROMBIN LOT 517467. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA FOR EVALUATION. ALTHOUGH WITHIN RANGE OF THE TABLES OF ASSIGNED VALUES, THE CUSTOMER OBSERVED AN INCREASE IN THE INTERNAL QUALITY CONTROL (QC) FOR BC THROMBIN LOT 517468 AND BC THROMBIN LOT 517469 COMPARED TO BC THROMBIN LOT 517467, WITH THE ALLOWABLE TOTAL ERROR (TEA) SOMETIMES EXCEEDING THE LABORATORY'S SPECIFICATION OF 10%. EXTERNAL QUALITY CONTROLS (RIQAS AND COBJWDL) WERE RUN BETWEEN MARCH AND JULY OF 2017 ON BC THROMBIN LOTS 517468 AND 517469 AND RECOVERED ABOVE THE EXPECTED VALUE(S). BASED ON THE VARIABILITY IN QUALITY CONTROL RECOVERY, THE LAB STOPPED RUNNING THE THROMBIN TIME TESTS ON PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839145 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970645. One submission often covers many models, so check the product and lot details in each record.

• Z-0827-2018 · Oct 17, 2017 · Terminated
  BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Te
• Z-0007-05 · Jul 21, 2004 · Terminated
  BC Thrombin Reagent . Thrombin Time Test