Recall Z-1101-04 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Beckman Coulter Inc
Synchron Systems Hemoglobin A1c (HbA1c) Reagent
| Date | Jul 20, 2004 (initiated Jul 30, 2004) |
| Status | Terminated |
| Reason | Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm. |
| Root cause | Other |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974452 | VIGIL LIPID CONTROL Beckman Instruments, Inc., Dec 17, 1997 |