remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk… recallZ-2928-2011 · Remel Inc · initiated Apr 21, 2011
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Organism strains may fail to consistently produce confluent growth
FDA root cause category: Other
What the company is doing
The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.
Recall details
- Recall number
- Z-2928-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 21, 2011
- Posted by the FDA
- Aug 3, 2011
- Recalling firm
- Remel Inc
- Quantity
- 223/10-pack boxes
- Product code
- JSO
- FDA submissions
- K892928
- Distribution
- Nationwide distribution.
Product description
remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Code information (models, lots, serial numbers)
Lot 014360, Exp. 2011.04.18; Lot 020424, Exp. 2011.04.26; and Lot 025985, Exp. 2011.05.09.
Other devices under the same FDA submission
2 devices cleared under K892928 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
Other products in the same recall event
The FDA groups related products into one recall event (event 58684).
- Z-2929-2011 · Terminatedremel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and L…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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