Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapol

FDA device recall Z-1824-2011 · posted 2011-03-25 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau

Action taken

The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.

Root cause

Other

Status

Terminated

Product code

CIC

Quantity affected

14,528 units

Distribution

Nationwide distribution.

Date initiated

2010-10-11

Date posted

2011-03-25

Date terminated

2011-09-13

Location

Indianapolis, IN

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