—#96430

Product

Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.

FDA product code: CIC — Cresolphthalein Complexone, Calcium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K963292
Affected lot / code info: Lots 62601901 and 63020401.

Why it was recalled

The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2010-10-11
Posted by FDA: 2011-03-25
Terminated: 2011-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.