Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 28, 2022
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Associates of Cape Cod, Inc. recalled Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 - a moderate-severity action.
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 was recalled by Associates of Cape Cod, Inc. in September 28, 2022. Reason: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to pri…. Check the official notice for the remedy. Verify recall #Z-1774-2022 with the FDA Devices before acting.
The recall
Associates of Cape Cod, Inc. issued this moderate-severity FDA Devices recall-Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to pri….
- Moderate
- severity level
- Class II
- classification
- September 28, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1774-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1774-2022) was formally reported on September 28, 2022, with the manufacturer initiating the action on August 17, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Associates of Cape Cod, Inc. is listed as the recalling firm, operating out of East Falmouth, MA. Federal records list the affected scope as 243 kits.
The documented reason for this recall is: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
243 kits
Related Recalls
6
6 from same agency
Product description
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Reason for recall
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1774-2022 |
| Date reported | September 28, 2022 |
| Date initiated | August 17, 2022 |
| Recalling firm | Associates of Cape Cod, Inc. |
| Firm location | East Falmouth, MA |
| Affected scope | 243 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK. |
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-1774-2022) 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? ▼
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007. Recalled by Associates of Cape Cod, Inc.. Units affected: 243 kits.
Why was this product recalled? ▼
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 28, 2022. Severity: Moderate. Recall number: Z-1774-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1774-2022) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 September 28, 2022. 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 August 2026.