Z-1524-2015Class II

MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels...

Name: Z-1524-2015 MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels...
Creator: Beckman Coulter, Inc.
Published: 2014-04-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-04-08 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of 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... on 2014-04-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1524-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-08
Posted: 2015-04-27
Terminated: 2015-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: 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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Catalog number B10170211; Siemens Material number (SMN): 1071530, lot number 2014-09-12.: Expiration date 2014-09-12.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code JWY

K870074Class IIGram Negative and Gram Positive Mic/combo PanelsMicroscan Div. Baxter Healthcare Corp. / cleared 1987-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)