FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
- Recall number
- Z-1176-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
- Status
- Terminated
- Initiated
- 2006-06-07
- Posted
- 2006-06-27
- Terminated
- 2008-04-23
- Reason
- Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.
- Quantity
- 933 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
- 510(k) numbers
- ["K041009"]
- PMA numbers
- not on file
- Product code
- CIC
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28