Recall Z-1111-2014 ยท OOI Real Time Nucleic Acid Amplification System
Roche Molecular Systems, Inc.
cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the coba
| Date | Feb 26, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from different lots of the cobas PCR Urine kits, cobas PCR Female Swab kits, and cobas PCR media kits. |
| Root cause | Device Design |
| Action | Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction letter/Fax-back form dated January 6, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the test-skpecific Instruction For Use for handling of cobas PCR media 4.3 ml IVD. The use of protective equipment should be worn as indicated in the labeling. Inspection each tube and/or blister packet for evidence of leakage prior to use. If leakage of the cobas PCR media 4.3 mL IVD is observed, do not use the tubes. Discard the affected tubes |
| Quantity | 84 kit batches |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110923 | COBAS 4800 CT / NG TEST Roche Molecular Systems, Inc., Jan 24, 2012 |