LA 1 Screening Reagent 10461887Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768007477), received between Mar 14, 2018 and Mar 14, 2018 — classified as 3 malfunctions.

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 16, 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.

• MalfunctionMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED LUPUS ANTICOAGULANTS (LA) 1 SCREENING REAGENT CLOTTING TIME RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING THE LA 1 SCREENING REAGENT. DUE TO THIS, THE SAMPLE WAS TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. BASED ON THE LAB'S RANGES, THE RATIO SIGNIFIED THAT THE PATIENT WAS POSITIVE FOR LA. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). A SAMPLE FROM THE SAME PATIENT WAS RUN ON AN ALTERNATE BCS XP SYSTEM AND LOWER LA 1 SCREENING REAGENT CLOTTING TIME AND LA 2 CONFIRMATION CLOTTING TIME RESULTS WERE OBTAINED ON THE PATIENT SAMPLE. IT IS UNKNOWN IF THE INITIAL RESULTS AND REPEAT RESULTS WERE OBTAINED USING THE SAME SAMPLE. THE RESULT OF 39.3 SECONDS WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LA 1 SCREENING REAGENT CLOTTING TIME RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339668 ↗
• MalfunctionMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED LUPUS ANTICOAGULANTS (LA) 1 SCREENING REAGENT CLOTTING TIME RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING THE LA 1 SCREENING REAGENT. DUE TO THE ELEVATED RESULT, THE SAMPLE WAS TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. BASED ON THE LAB'S RANGES, THE RATIO SIGNIFIED THAT THE PATIENT WAS POSITIVE FOR LA. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RERUN ON AN ALTERNATE BCS XP SYSTEM, RESULTING IN A LOWER LA 1 SCREENING REAGENT CLOTTING TIME RESULT. THE SAMPLE WAS ALSO TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. THE RATIO SIGNIFIED THAT THE PATIENT WAS WEAKLY POSITIVE FOR LA. SINCE THE PATIENT'S ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND FACTOR VIII RESULTS RECOVERED WITHIN NORMAL RANGES, A LA RATIO OF 1.3 WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LA 1 SCREENING REAGENT CLOTTING TIME RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339667 ↗
• MalfunctionMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED LUPUS ANTICOAGULANTS (LA) 1 SCREENING REAGENT CLOTTING TIME RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM (SERIAL NUMBER (SN) (B)(4)) USING THE LA 1 SCREENING REAGENT. DUE TO THE ELEVATED RESULT, THE SAMPLE WAS TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. BASED ON THE LAB'S RANGES, THE RATIO SIGNIFIED THAT THE PATIENT WAS POSITIVE FOR LA. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RERUN ON AN ALTERNATE BCS XP SYSTEM (SN (B)(4)), RESULTING IN A LOWER LA 1 SCREENING REAGENT CLOTTING TIME RESULT. THE SAMPLE WAS TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. THE RATIO OF 0.9 WAS REPORTED TO THE PHYSICIAN(S), INDICATING THAT THE PATIENT WAS NEGATIVE FOR LA AND THIS WAS CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS FROZEN AND RERUN ON (B)(6) 2018 ON AN ALTERNATE BCS XP SYSTEM (SN (B)(4)), RESULTING IN A LOWER LA 1 SCREENING REAGENT CLOTTING TIME RESULT THAN THE INITIAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339663 ↗