Recall Z-0027-04 ยท LNW Paper, Obstetric Ph
Instrumentation Laboratory Co.
Lactate Disposable Membrane Caps Product Number: 0018108400
| Date | Oct 15, 2003 (initiated Aug 28, 2003) |
| Status | Terminated |
| Reason | Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L. |
| Root cause | Other |
| Action | Instrumentation Laboratories notified two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s). IL service also dispatched to customer sites on September 4, 2003. International Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, |
| Quantity | 287 boxes |
| Distribution | IL, NY International: Italy, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.