Erytra 210401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08437014205190), received between Jun 4, 2020 and Jun 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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.

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.

• MalfunctionJun 4, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2020, THE CUSTOMER (B)(6), REPORTED TO GRIFOLS A SAMPLE BARCODE READING ERROR OCCURRED DURING THE VALIDATION/CORRELATION OF A CROSSMATCH TEST. THE ERYTRA FULLY AUTOMATED IMMUNOHEMATOLOGY ANALYZER READ THE DONOR SAMPLE BARCODE AS (B)(6) INSTEAD OF THE EXPECTED NUMBER (B)(6). THE EVENT WAS DETECTED BY THE OPERATOR WHEN CHECKING THE BARCODES TO REPEAT THE CROSSMATCH TESTS MANUALLY. THE SAME BARCODE WAS LATER READ AGAIN WITH THE SAME INSTRUMENT AND WITH ANOTHER ERYTRA ANALYZER, AND THE BARCODE WAS READ CORRECTLY. THE CUSTOMER CONFIRMS THAT THIS WAS THE FIRST AND ONLY TIME THE DEVICE HAS MISREAD A BARCODE NUMBER. THE BARCODE WAS AN ISBT128 WITH CHECKSUM FROM A DONOR'S BAG FROM THE RED CROSS UNIT. NOTE THAT WHEN THE CUSTOMER IS WORKING IN ROUTINE CONDITIONS, THE INSTRUMENT IS INTERFACED WITH THE LIS. THE LIS WOULD DETECT THE DISCREPANCY BECAUSE THE WRONG CODE EITHER WOULD NOT EXIST OR WOULD NOT CORRESPOND TO A SAMPLE PREVIOUSLY SENT TO THE ANALYZER, PRECLUDING THE POSSIBILITY OF RELEASING THE ASSOCIATED TESTS RESULT TO AN INCORRECT SAMPLE IDENTIFICATION NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10117514 ↗