# FDA recall Z-1276-2018

> **Phadia Ab** · Class II · device recall initiated 2017-11-20.

## Product

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).

## Distribution

US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR

## Key facts

- **Recall number:** Z-1276-2018
- **Recalling firm:** Phadia Ab
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-20
- **Report date:** 2018-04-11
- **Termination date:** 2019-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uppsala, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1276-2018

## Citation

> AI Analytics. FDA recall Z-1276-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1276-2018. Source: US FDA. Licensed CC0.

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