| Date Initiated by Firm | January 10, 2003 |
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| Date Posted | February 21, 2003 |
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| Recall Status1 |
Terminated 3 on June 03, 2003 |
| Recall Number | Z-0558-03 |
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| Recall Event ID |
25394 |
| 510(K)Number | K964310 |
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| Product | Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793 |
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| Code Information |
Lot 5003, Exp. 12 September 2003 |
Recalling Firm/
Manufacturer |
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
|
| For Additional Information Contact | Sherry Phillips
585-453-3728 |
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Manufacturer Reason
for Recall | Label printing irregularities on cartons and/or bottles. |
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FDA Determined
Cause 2 | Other |
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| Action | Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print. |
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| Quantity in Commerce | 284 cartons/2 bottles per carton |
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| Distribution | Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A.
No product was shipped outside the U.S. |
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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 =
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