Recall Z-0499-2007 ยท J
EMD Chemicals Inc
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
| 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 | 800 packages of 50 strips each. |
| 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.