N/A 340757Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903407576), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 22, 2021Terminated

   Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

   Z-2333-2021 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MS IGG2A ISOTYPE CONTROL APC X39 ASR GAVE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6): (B)(6) 2020, 20:00:27 (GMT). DATA SENT BY CUSTOMER. (B)(6): (B)(6) 2020, 19:59:42 (GMT). ADDITIONAL INFORMATION FROM CUSTOMER: I RECEIVED THIS SAME LOT ON A PREVIOUS ORDER FROM (B)(6) 2020. WE USE THIS ISOTYPE FOR LDT IMMUNE PANELS. IN THE PAST WE HAVE NOTICED SOME PATIENT'S LYMPHOCYTES REACT WITH THIS LOT OF IGG2A ANTIBODY (MAYBE CLONE SPECIFIC) AND BE POSITIVE. WE ORDERED IT IN NOVEMBER AND RECEIVED THE SAME LOT. WE HAVE USED THREE DIFFERENT CELLS SO FAR WITH THIS SHIPMENT AND SEEN POSITIVE POPULATIONS PAST THE 103 LOG DECADE. WE USE 5UL OF THE IGG2A APC ANTIBODY BY ITSELF WHEN PERFORMING QC IN PARALLEL WITH THE CURRENT LOT. WE USE A LYSED PROTOCOL FOR A CELL SUSPENSION AND USE UP TO ONE MILLION CELLS IN A 100UL VOLUME FOR STAINING. IT IS ANALYZED USING A BD FACSCANTO II FLOW CYTOMETER. (B)(6): (B)(6) 2020 17:10:30 (GMT) REVIEWED, PENDING REPLACEMENT PRODUCT. MATERIAL NO: 340757; BATCH NO: 0253432. IT WAS REPORTED THAT THE REAGENT IS SHOWING HIGH BACKGROUND. (B)(6): (B)(6) 2020 01:01:34 (GMT) REQUESTED DATA AND DETAILS ON PROTO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11103438 ↗