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LowClass IIITerminated

FDA Devices recall · Reported December 25, 2013

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

Boxes labeled as CIP5 may contain cartridges of AMP5.

Recall #
Z-0528-2014
Affected scope
60/5/50-disc cartridge boxes
Initiated
November 21, 2012
Compiled from official public sources by the editorial team.
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Remel Inc recalled Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs … - a low-severity action.

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs … was recalled by Remel Inc in December 25, 2013. Reason: Boxes labeled as CIP5 may contain cartridges of AMP5.. Check the official notice for the remedy. Verify recall #Z-0528-2014 with the FDA Devices before acting.

The recall

Remel Inc issued this low-severity FDA Devices recall-Boxes labeled as CIP5 may contain cartridges of AMP5..

Low
severity level
Class III
classification
December 25, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0528-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0528-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on November 21, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Remel Inc is listed as the recalling firm, operating out of Lenexa, KS. Federal records list the affected scope as 60/5/50-disc cartridge boxes.

The documented reason for this recall is: Boxes labeled as CIP5 may contain cartridges of AMP5. Distribution data in the federal record shows the product reached: Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

60/5/50-disc cartridge boxes

Related Recalls

6

3 from same agency

Product description

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

Reason for recall

Boxes labeled as CIP5 may contain cartridges of AMP5.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-0528-2014
Date reported December 25, 2013
Date initiated November 21, 2012
Recalling firm Remel Inc
Firm location Lenexa, KS
Affected scope 60/5/50-disc cartridge boxes
Distribution Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0528-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.. Recalled by Remel Inc. Units affected: 60/5/50-disc cartridge boxes.
Why was this product recalled?
Boxes labeled as CIP5 may contain cartridges of AMP5.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 25, 2013. Severity: Low. Recall number: Z-0528-2014.
Where was the recalled product distributed?
Distribution: Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0528-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 25, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.