Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 11, 2018
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when reject…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Phadia Ab recalled Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia … - a moderate-severity action.
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia … was recalled by Phadia Ab in April 11, 2018. Reason: We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All …. Check the official notice for the remedy. Verify recall #Z-1276-2018 with the FDA Devices before acting.
The recall
Phadia Ab issued this moderate-severity FDA Devices recall-We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All ….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- April 11, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1276-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1276-2018) was formally reported on April 11, 2018, with the manufacturer initiating the action on November 20, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Phadia Ab is listed as the recalling firm, operating out of Uppsala, N/A. Federal records list the affected scope as 2307.
The documented reason for this recall is: We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA … Distribution data in the federal record shows the product reached: US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2307
Related Recalls
6
3 from same agency
Product description
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
Reason for recall
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1276-2018 |
| Date reported | April 11, 2018 |
| Date initiated | November 20, 2017 |
| Recalling firm | Phadia Ab |
| Firm location | Uppsala, N/A |
| Affected scope | 2307 |
| Distribution | US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR |
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-1276-2018) 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? ▼
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.. Recalled by Phadia Ab. Units affected: 2307.
Why was this product recalled? ▼
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1276-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1276-2018) 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 April 11, 2018. 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.