| Date Initiated by Firm | May 09, 2002 |
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| Date Posted | August 17, 2004 |
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| Recall Status1 |
Terminated 3 on September 15, 2004 |
| Recall Number | Z-1376-04 |
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| Recall Event ID |
29681 |
| 510(K)Number | K031965 |
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| Product Classification |
Cryptosporidium Spp. - Product Code MHJ
|
| Product | ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096. |
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| Code Information |
910717 912101 |
Recalling Firm/
Manufacturer |
Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
|
Manufacturer Reason
for Recall | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended. |
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FDA Determined
Cause 2 | Other |
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| Action | A potential stability problem has been identified with the positive control in the ProSpecT CryptoSporidium Microplate Assay. The positive control may not perform as intended through its expiration date and may invalidate an otherwise acceptable run. |
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| Quantity in Commerce | 388 kits (187 - 910717, 201 - 912101) |
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| Distribution | in the US |
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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 = MHJ
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