Recall Z-1436-2011 ยท MDK Dna-Probe, Reagents, Streptococcal
Gen-Probe Inc
Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
| Date | Mar 10, 2011 (initiated Dec 30, 2008) |
| Status | Terminated |
| Reason | This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results. |
| Root cause | Process control |
| Action | Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the |
| Quantity | 1055 kits |
| Distribution | Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974572 | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 Chugai Pharmaceuticals Co., Ltd., Sep 24, 1998 |