| Date Initiated by Firm | June 07, 2006 |
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| Date Posted | June 27, 2006 |
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| Recall Status1 |
Terminated 3 on April 23, 2008 |
| Recall Number | Z-1176-06 |
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| Recall Event ID |
35493 |
| 510(K)Number | K041009 |
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| Product Classification |
Cresolphthalein Complexone, Calcium - Product Code CIC
|
| Product | Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160. |
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| Code Information |
Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07). |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-428-2336 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 933 kits |
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| Distribution | Nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = CIC
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