Recall Z-1607-2008 ยท DNN Calibrators, Ethyl Alcohol
EMD Chemicals Inc
EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.
| Date | Sep 16, 2008 (initiated Mar 27, 2008) |
| Status | Terminated |
| Reason | Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard. |
| Root cause | Process control |
| Action | VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail. |
| Quantity | 99 cases (10 ampules per case) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc., Mar 31, 1999 |