MicroScan -Neg Breakpoint Combo Panel Type 34 recallZ-1522-2015 · Beckman Coulter, Inc. · initiated May 14, 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 Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
FDA root cause category: Equipment maintenance
What the company is doing
Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031
Recall details
- Recall number
- Z-1522-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 14, 2014
- Posted by the FDA
- Apr 26, 2015
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 681 boxes
- Product code
- JWY
- FDA submissions
- K862140
- Distribution
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
Product description
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
Code information (models, lots, serial numbers)
Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
Other devices under the same FDA submission
1 device cleared under K862140 — 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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