Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 19, 2018
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the s…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
The Binding Site Group, Ltd. recalled Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction… - a moderate-severity action.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction… was recalled by The Binding Site Group, Ltd. in December 19, 2018. Reason: Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM…. Check the official notice for the remedy. Verify recall #Z-0604-2019 with the FDA Devices before acting.
The recall
The Binding Site Group, Ltd. issued this moderate-severity FDA Devices recall-Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM….
- Moderate
- severity level
- 60 units
- affected scope
- Class II
- classification
- December 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0604-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0604-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on November 6, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. The Binding Site Group, Ltd. is listed as the recalling firm, operating out of Birmingham, N/A. Federal records list the affected scope as 60.
The documented reason for this recall is: Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges. Distribution data in the federal record shows the product reached: U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,. 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
60
Related Recalls
6
3 from same agency
Product description
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
Reason for recall
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0604-2019 |
| Date reported | December 19, 2018 |
| Date initiated | November 6, 2018 |
| Recalling firm | The Binding Site Group, Ltd. |
| Firm location | Birmingham, N/A |
| Affected scope | 60 |
| Distribution | U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA, |
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-0604-2019) 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? ▼
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.. Recalled by The Binding Site Group, Ltd.. Units affected: 60.
Why was this product recalled? ▼
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0604-2019.
Where was the recalled product distributed? ▼
Distribution: U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0604-2019) 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 19, 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.