Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported November 6, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Drg International, Inc. recalled 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro… - a low-severity action.
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro… was recalled by Drg International, Inc. in November 6, 2024. Reason: The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance…. Check the official notice for the remedy. Verify recall #Z-0258-2025 with the FDA Devices before acting.
The recall
Drg International, Inc. issued this low-severity FDA Devices recall-The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance….
- Low
- severity level
- 504 units
- affected scope
- Class III
- classification
- November 6, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0258-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0258-2025) was formally reported on November 6, 2024, with the manufacturer initiating the action on September 13, 2024. It is classified under Low severity (Class III), with a current status of Ongoing. Drg International, Inc. is listed as the recalling firm, operating out of Springfield, NJ. Federal records list the affected scope as 504 units.
The documented reason for this recall is: The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provi… Distribution data in the federal record shows the product reached: AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam. 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
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.
Affected scope
504 units
Related Recalls
6
3 from same agency
Product description
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
Reason for recall
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0258-2025 |
| Date reported | November 6, 2024 |
| Date initiated | September 13, 2024 |
| Recalling firm | Drg International, Inc. |
| Firm location | Springfield, NJ |
| Affected scope | 504 units |
| Distribution | AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam |
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-0258-2025) 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? ▼
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292. Recalled by Drg International, Inc.. Units affected: 504 units.
Why was this product recalled? ▼
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Low. Recall number: Z-0258-2025.
Where was the recalled product distributed? ▼
Distribution: AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0258-2025) 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 November 6, 2024. 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.