FDA Device Recall Z-0024-05: Remel, Inc.

Recall Res Number

Z-0024-05

Recalling Firm / Manufacturer

Remel, Inc.

FEI Number

1924669

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-27

Date Posted

2004-10-20

Date Terminated

2006-04-25

Product Code

KZI

Event Number

30154

Product Quantity

4,620 units (308 packages)

Product Description Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

Reason for Recall The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

Action Details The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.

Distribution Pattern Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.

Code Information / Serial Numbers Lot #435902, Exp. 2004-11-04

BECTON, DICKINSON & CO. Registration: 1111096 View Registration
BECTON, DICKINSON & CO. Registration: 1119779 View Registration
ALPHA BIOSCIENCES, INC. Registration: 1125797 View Registration
ANALYTICHEM USA, INC. Registration: 1210083 View Registration
PURITAN MEDICAL PRODUCTS COMPANY LLC Registration: 1216735 View Registration
OXYRASE, INC. Registration: 1530248 View Registration
REMEL, INC. Registration: 1924669 View Registration
HARDY DIAGNOSTICS Registration: 2022807 View Registration
ANAEROBE SYSTEMS Registration: 2916932 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182157 View Registration
HIMEDIA LABORATORIES PRIVATE LIMITED Registration: 3005182159 View Registration
Hardy Diagnostics Registration: 3009547954 View Registration
S2MEDIA Registration: 3012162776 View Registration
OXFORD IMMUNOTEC LTD Registration: 3015492990 View Registration
LEGACY BIOLOGICALS Registration: 3015715780 View Registration
JINAN BABIO BIOTECHNOLOGY CO.,LTD. Registration: 3016741564 View Registration
CREATIVE LIFE SCIENCE CO., LTD. Registration: 3038136284 View Registration

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Medical Device Recall: Z-0024-05

Recall Parameters & Description

Related Establishments / Registrations

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