Severity
Low
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Reported: July 27, 2022 Initiated: June 9, 2022 #Z-1422-2022 12 kits (US) units
Randox Laboratories Ltd. issued this FDA Devices recall on July 27, 2022. Classified as Low severity (Class III). Approximately 12 kits (US) units are affected. The recall was issued because: A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and con…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1422-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on June 9, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Randox Laboratories Ltd. is listed as the recalling firm, operating out of Crumlin (North), N/A. Federal records indicate 12 kits (US) units are affected.
The documented reason for this recall is: A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
12 kits (US)
Related Recalls
6
6 from same agency
Product Description
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Reason for Recall
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 12 kits (US)
- Distribution
- US Nationwide distribution in the state of IL.
- Location
- Crumlin (North), N/A
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1422-2022 |
| Date reported | July 27, 2022 |
| Date initiated | June 9, 2022 |
| Recalling firm | Randox Laboratories Ltd. |
| Units affected | 12 kits (US) |
| Distribution | US Nationwide distribution in the state of IL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD. Recalled by Randox Laboratories Ltd.. Units affected: 12 kits (US).
Why was this product recalled? ▼
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Low. Recall number: Z-1422-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1422-2022) 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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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).