| |
Class 2 Device Recall Oxoid Legionella Pneumo Groups 214 |
 |
| Date Initiated by Firm |
March 17, 2014 |
| Date Posted |
April 18, 2014 |
| Recall Status1 |
Terminated 3 on December 11, 2014 |
| Recall Number |
Z-1474-2014 |
| Recall Event ID |
67777 |
| Product Classification |
General purpose microbiology diagnostic device - Product Code LIB
|
| Product |
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. |
| Code Information |
DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014 |
Recalling Firm/
Manufacturer |
Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
|
| For Additional Information Contact |
Earleen C. Parks
913-895-4185
|
Manufacturer Reason
for Recall |
A reagent contained within the product may return false negative results.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers. |
| Quantity in Commerce |
2/50-test boxes |
| Distribution |
Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
|
|
|
