Recall Z-0683-03 ยท LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
EMD Chemicals Inc
Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
| Date | Mar 26, 2003 (initiated Dec 13, 2002) |
| Status | Terminated |
| Reason | The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL. |
| Root cause | Other |
| Action | All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003. |
| Quantity | 279 cases of 10 ampules |
| Distribution | The Ethanol Products were distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Fisher Scientific, 2000 Park Lane, |
| 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 |