Recall Z-1524-2015 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
| Date | Apr 27, 2015 (initiated Apr 8, 2014) |
| Status | Terminated |
| Reason | Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch. |
| Root cause | Process control |
| Action | Siemens sent an Urgent Medical Device Recall letter dated April 8, 2014, to all affected customers. Letters advised users of the recalled product with catalog number, Siemens Material Number and Lot number as well as the reason for recall. The risk to health was explained as well as the recommendation for discussing the content of the letter with the medical director regarding the need to review previous test results. Customers are asked to discontinue use and discard any remaining inventory of the PC33 panel 2014-09-12. All other lot numbers are not impacted. The attached confirmation receip |
| Quantity | 664 panel boxes |
| Distribution | Nationwide Distribution including Puerto Rico and to the states of : CT, GA, NC, OK, NY, SC, KY, TN, CA, WA, OR, NJ, OH, PA, FL, MI, TX, WI, MO and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS Microscan Div. Baxter Healthcare Corp., Apr 14, 1987 |