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MicroScan Microbiology Systems: Dried Gram Negative… recallZ-1529-2015 · Beckman Coulter, Inc. · initiated Aug 8, 2014

Class II Terminated All recalls posted in April 2015

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

FDA root cause category: Labeling False and Misleading

What the company is doing

The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: [email protected] or your local Siemens technical support representative.

Recall details

Recall number
Z-1529-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 8, 2014
Posted by the FDA
Apr 27, 2015
Recalling firm
Beckman Coulter, Inc.
Quantity
Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
Product code
JWY
FDA submissions
K870074
Distribution
Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.

Product description

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Code information (models, lots, serial numbers)

Catalog number: B1017-417; Siemens Material Number (SMN): 10483099.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 70893).

Sources and updates

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