Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Mi

FDA device recall Z-1563-2013 · posted 2013-06-21 · Terminated

Recall details

Recalling firm

Microgenics Corporation

Reason for recall

It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

Action taken

ThermoFisher Scientific sent a Product Recall Notification letter dated May 13, 2013, by Certified US mail to all affected customer. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed 1. Determine if you are using or have inventory of the recalled product. 2. Discontinue use of the product immediately. 3. Evaluate quality controls. They may vary among laboratories and should be evaluated according to laboratory procedures. 4. Retain a copy of the letter for laboratory records. 5. If any of the affected lots of MAS Bilirubin had been forwarded to another laboratory, please provide a copy of the recall letter to them. 6. Complete and return the response form within 5 days. Letters also provide an alternative product - MAS Bilirubin part number BC103. Questions or concerns may be directed to Technical Services at 1-800-232-3342 or 510-979-5417.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JJX

Quantity affected

188

Distribution

Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.

Date initiated

2013-05-13

Date posted

2013-06-21

Date terminated

2013-08-27

Location

Fremont, CA

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