Recall Z-0649-05 ยท LCP Assay, Glycosylated Hemoglobin
Roche Diagnostics Corp.
Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
| Date | Mar 23, 2005 (initiated Feb 15, 2005) |
| Status | Terminated |
| Reason | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. |
| Root cause | Other |
| Action | Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility. |
| Quantity | 347,000 cassettes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003120 | MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C Roche Diagnostics Corp., Dec 18, 2000 |