Recall Z-1498-2012 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Siemens Healthcare Diagnostics, Inc.
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
| Date | May 8, 2012 (initiated Jun 16, 2011) |
| Status | Terminated |
| Reason | Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels. |
| Root cause | Process control |
| Action | Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication. |
| Quantity | 680 boxes (20 panels per box) |
| Distribution | Worldwide Distribution -- US, Turkey, Poland, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862140 | MICRODILUTION PANELS American Micro Scan, Jul 16, 1986 |