MicroScan Pos Combo Panel Type 33 (PC33) recallZ-1524-2015 · Beckman Coulter, Inc. · initiated Apr 8, 2014
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 receipt is to be completed and returned and the letter should remain with laboratory records. Questions should be directed to Siemens Customer Care Center. For further questions call (916) 374-3031.
Recall details
- Recall number
- Z-1524-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 8, 2014
- Posted by the FDA
- Apr 27, 2015
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 664 panel boxes
- Product code
- JWY
- FDA submissions
- K870074
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Catalog number B10170211; Siemens Material number (SMN): 1071530, lot number 2014-09-12.: Expiration date 2014-09-12.
Other devices under the same FDA submission
1 device cleared under K870074 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MicroScan B1017-216Beckman Coulter, Inc. · Susceptibility Test Cards, Antimicrobial1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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