| Date Initiated by Firm | February 15, 2005 |
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| Date Posted | March 23, 2005 |
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| Recall Status1 |
Terminated 3 on May 17, 2005 |
| Recall Number | Z-0650-05 |
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| Recall Event ID |
31056 |
| 510(K)Number | K952337 |
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| Product Classification |
Assay, Glycosylated Hemoglobin - Product Code LCP
|
| Product | Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. |
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| Code Information |
Lots 646340, 650984, 651640 and 653292. |
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 | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. |
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FDA Determined
Cause 2 | Other |
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| Action | Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility. |
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| Quantity in Commerce | 1800 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 = LCP
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