Recall Z-0498-2007 ยท J
EMD Chemicals Inc
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
| Date | Feb 17, 2007 (initiated Aug 17, 2006) |
| Status | Terminated |
| Reason | Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present. |
| Root cause | Other |
| Action | A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return. |
| Quantity | 8 rolls |
| Distribution | Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.