| Class 3 Device Recall Remel Chocolate Agar | |
Date Initiated by Firm | September 27, 2004 |
Date Posted | October 20, 2004 |
Recall Status1 |
Terminated 3 on April 25, 2006 |
Recall Number | Z-0024-05 |
Recall Event ID |
30154 |
Product Classification |
Culture Media, Enriched - Product Code KZI
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Product | Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS. |
Code Information |
Lot #435902, Exp. 2004-11-04 |
Recalling Firm/ Manufacturer |
Remel, Inc. 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478) Lenexa KS 66215-3519
|
For Additional Information Contact | Robert Booth 913-895-4007 |
Manufacturer Reason for Recall | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
FDA Determined Cause 2 | Other |
Action | The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot. |
Quantity in Commerce | 4,620 units (308 packages) |
Distribution | Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK. |
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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